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OpenTrials
Completed

NCT Number: NCT06323655

Evaluation of Next-Day Residual Effects of Tasimelteon Compared With Placebo and Active Control in Healthy Subjects

The aim of this study is to investigate next-day residual effects of tasimelteon compared with placebo and active control in healthy subjects.

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Key information

Conditions

Healthy Volunteers

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Vanda Investigational Site

Laval, Quebec, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to provide written consent;
  • Healthy subjects with no medical, psychiatric, or current sleep disorders;
  • Men and women ages 21 - 55, inclusive;
  • Possession of a valid driver's license ≥ 3 years with reported annual mileage ≥ 3,000 km.

Exclusion criteria

  • Pregnancy or recent pregnancy;
  • Subjects who are unable to read or speak English or French.

Treatment and study plan

tasimelteon

Drug

oral capsule

Active Control Placebo

Drug

oral capsule

Tasimelteon Placebo

Drug

oral capsule

Active Control

Drug

oral capsule

Primary outcomes

  1. Next-day effects on simulated driving performance as measured by changes in Standard Deviation of Lateral Position (SDLP)

    Time frame: Day 1 of Treatment Period 1, Treatment Period 2, and Treatment Period 3 (each Period is 1 day, separated by washout)

Sponsors and collaborators

Lead sponsor

Vanda Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Double-blind, Double-dummy, Placebo-controlled, Three-way Crossover Study in Healthy Subjects to Evaluate the Next-day Residual Effects of 20 mg Tasimelteon

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 21, 2024
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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